Biomedical Ethics Unit/Social Studies of Medicine, McGill University, Montreal, Quebec.
J Law Med Ethics. 2012 Winter;40(4):841-7. doi: 10.1111/j.1748-720X.2012.00712.x.
Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.
临床纳米医学试验对现行的以人体为中心的研究伦理框架提出了两个挑战。首先，一些纳米医学应用可能会给研究对象以外的人带来风险。其次，在测试纳米药物时遇到的压力可能会对支持临床转化和弥补研究风险所需的合作和集体活动构成威胁。在本文中，我描述了在基因转移中是如何遇到和解决这些类似的挑战的，并勾勒出在纳米医学转化领域可能探索的政策选择。
